To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches

Summary

To determine the efficacy of the Trexima versus placebo as assessed by pain relief and the incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary endpoints.

Timeline

Start

2004-08

Primary completion

—

Completion

2005-04

Outcome

Mixed primary results

paper Sumatriptan-naproxen sodium was more effective than placebo for headache relief at 2 hours after dosing (study 1, 65% vs 28%; P<.001 PMID 17405970 ↗

paper and study 2, 57% vs 29%; P<.001 PMID 17405970 ↗

paper For 2- to 24-hour sustained pain-free response, sumatriptan-naproxen sodium was superior at P<.01 PMID 17405970 ↗

paper in study 2 rates of absence of nausea did not differ between sumatriptan-naproxen sodium and placebo (65% vs 64%; P = .71). PMID 17405970 ↗

Publications

• Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naproxen	Small molecule	500 mg	—
Subject	Sumatriptan	Unknown	85 mg	—

Indications